Developing translational research infrastructure and capabilities associated with cancer clinical trials

Hall, Jacqueline A.; Brown, Robert E.

doi:10.1017/erm.2013.12

Cited by 4 publications

(2 citation statements)

References 64 publications

(73 reference statements)

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“…Sometimes, clinical trials may require biospecimens for translational research and/or confirmation of trial eligibility but regulatory requirements related to the acquisition and management of biospecimens are heterogeneous across countries and may also affect activation timelines [ 2 , 17 , 18 ]. In some regions, it might be necessary to set up parallel biobanks or laboratories, which will need quality assurance processes to ensure reliability of the generated data [ 18 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial

Franzoi¹,

Procter²,

Twelves³

et al. 2022

ecancer

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Background Geographic location and national income may influence access to innovation in healthcare. We aimed to study if geographical location and national income influenced the timelines to activate the global phase III APHINITY trial, evaluating adjuvant pertuzumab in patients with HER2-positive early breast cancer. Methods Time from regulatory authority (RA) submission to approval (RAA), time to Ethics Committee/Institutional Review Board (EC/IRB) approval, time from study approval by EC/IRB to first randomised patient and from first to last randomised patient were collected. Analyses were conducted grouping countries by geographical region or economic income classification. Results Forty-one countries (of 42) had data available regarding all relevant timelines. No statistical difference was observed between the time to RAA and geographical region ( p = 0.47), although there was a trend to longer time to RAA in upper middle-income economies ( p = 0.07). Except for time from first to last patient randomised, there was wide variation in timelines overall and within geographical regions and economic income groups. Conclusions Geographical location and income classification did not appear to be the major drivers influencing time for clinical trial activation. Wide variability in activation timelines within geographical regions and income groups exists and is worthy of further investigation.

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Section: Discussionmentioning

confidence: 99%

Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial

Franzoi¹,

Procter²,

Twelves³

et al. 2022

ecancer

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“…Beside the tissue that has been retrieved and stored based on rigid standardized operating procedures (SOPs) high quality clinical data are necessary. To provide an excellent platform for translational research tissue acquisition and clinical data collection are best performed within clinical trials 1 . This requires a well-developed information technology (IT) infrastructure 2 that is of increasing importance if patient numbers are high and combinations of clinical data, biomaterial and molecular results are warranted.…”

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confidence: 99%

Neoadjuvant Therapy in Rectal Cancer - Biobanking of Preoperative Tumor Biopsies

Nietert

Gusky

et al. 2016

Sci Rep

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Translational research relies on high-quality biospecimens. In patients with rectal cancer treated preoperatively with radiochemotherapy tissue based analyses are challenging. To assess quality challenges we analyzed tissue samples taken over the last years in a multicenter setting. We retrospectively evaluated overall 197 patients of the CAO/ARO/AIO-94- and 04-trial with locally advanced rectal cancer that were biopsied preoperatively at the University Medical Center Goettingen as well as in 10 cooperating hospitals in Germany. The cellular content of tumor, mucosa, stroma, necrosis and the amount of isolated DNA and RNA as well as the RNA integrity number (RIN) as quality parameters were evaluated. A high RNA yield (p = 2.75e–07) and the content of tumor (p = 0.004) is significantly associated to high RIN-values, whereas a high content of mucosa (p = 0.07) shows a trend and a high amount of necrosis (p = 0.01) is significantly associated with RNA of poor quality. Correlating biopsies from Goettingen and the cooperating centers showed comparable tumor content results. By taking small sized biopsies we could assess a clear correlation between a good RNA quality and a high amount of RNA and tumor cells. These results also indicate that specimens collected at different centers are of comparable quality.

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Cancer Gene Profiling for Response Prediction

Ghadimi

2016

Methods in Molecular Biology

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The revolution of genomic technologies, including gene expression profiling, high-resolution mapping of genomic imbalances, and next-generation sequencing, allows us to establish molecular portraits of cancer cells with unprecedented accuracy. This generates hope and justifies anticipation that disease diagnosis, prognosis, and the choice of treatment will be adapted to the individual needs of patients based on molecular evidence. Preoperative treatment strategies are now recommended for a variety of human cancers. Unfortunately, the response of individual tumors to a preoperative treatment is not uniform, and ranges from complete regression to resistance. This poses a considerable clinical dilemma, as patients with a priori resistant tumors could either be spared exposure to radiation or DNA-damaging drugs, i.e., could be referred to primary surgery, or dose-intensified protocols could be pursued. Because the response of an individual tumor as well as therapy-induced side effects represent the major limiting factors of current treatment strategies, identifying molecular markers of response or for treatment toxicity has become exceedingly important. However, complex phenotypes such as tumor responsiveness to multimodal treatments probably do not depend on the expression levels of just one or a few genes and proteins. Therefore, methods that allow comprehensive interrogation of genetic pathways and networks hold great promise in delivering such tumor-specific signatures, since expression levels of thousands of genes can be monitored simultaneously. Over the past few years, microarray technology has emerged as a central tool in addressing pertinent clinical questions, the answers to which are critical for the realization of a personalized genomic medicine, in which patients will be treated based on the biology of their tumor and their genetic profile (Quackenbush, N Engl J Med 354:2463-72, 2006; Jensen et al., Curr Opin Oncol 18:374-380, 2006; Bol and Ebner, Pharmacogenomics 7:227-235, 2006; Nevins and Potti, Nat Rev Genet 8:601-609, 2007).

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Developing translational research infrastructure and capabilities associated with cancer clinical trials

Cited by 4 publications

References 64 publications

Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial

Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial

Neoadjuvant Therapy in Rectal Cancer - Biobanking of Preoperative Tumor Biopsies

Cancer Gene Profiling for Response Prediction

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